Summary
Overview
Work History
Education
Skills
Websites
Awards
Languages
Disclaimer
Timeline
Generic
Lakshmi Suvarna

Lakshmi Suvarna

Hyderabad

Summary

Results-driven professional with 4.5 years of experience in pharmaceutical safety, specializing in team collaboration to identify and resolve safety issues. Proven ability to adapt quickly to new challenges and environments while maintaining a strong work ethic. Exceptional interpersonal skills enhance teamwork and communication. Demonstrated capability to work independently and master new skills efficiently.

Overview

4
4
years of professional experience

Work History

PMS Complaint Handling Investigator

4C Pharma Solutions
10.2022 - Current
  • Monitored and evaluated product performance and safety post-release to ensure compliance with regulations.
  • Created and submitted regular reports to regulatory bodies detailing product performance and safety metrics.
  • Analyzed complaint data to identify trends and root causes, generating detailed management reports for improvement.
  • Submitted adverse event reports, ICSRs, and PSURs while responding to health authority inquiries.
  • Reviewed clinical analyses and investigations of reportable complaints, mentoring team on clinical decision-making.
  • Provided training and support to enhance team skills in complaint handling and regulatory knowledge.
  • Communicated with cross-functional groups and subject matter experts to drive positive outcomes.
  • Participated in CAPA board activities, audits, and process improvement initiatives.

Safety Physician II (Medical Reviewer)

INDEGENE
Bangalore
11.2021 - 10.2022
  • Reviewed and contributed to Safety Management Plans, Signal Detection Plans, and Risk Management Plans.
  • Approved selection of adverse events from source documents; assigned coding using MedDRA and WHO-Drug dictionaries.
  • Conducted medical review of clinical trial cases, focusing on prioritization and regulatory reporting.
  • Oversaw vendor processing of single case medical reviews for specific therapeutic areas.
  • Prioritized adverse event report processing in accordance with ICH guidelines.
  • Executed end-to-end case processing activities in pharmacovigilance databases, including Argus and ARISg.
  • Evaluated reportability of cases for regulatory submission to local and international authorities.
  • Facilitated aggregate report preparation for Annual Safety Reports, including PSURs, DSURs, and PBRERs.

Drug Safety Associate

IQVIA MEDICAL COMPANY
Bangalore
03.2021 - 11.2021
  • Company Overview: Bangalore
  • Processed SAEs, Spontaneous Reports, Literature reports, Solicited cases, Pregnancy cases, Intake of ICSRs and other medically related information in ARGUS safety database.
  • Performed Book-in, Triage and data entry, coding relevant medical terminology, writing descript narratives, generating queries pertinent to case and managed 100 percent regulatory compliance in ICSR processing throughout tenure.
  • Conducted literature searches to identify potential signals related to marketed products.
  • Performed Quality control for assessed cases for errors, missing information, and legibility.
  • Bangalore

Clinical Pharmacologist

APOLLO HOSPITALS
Hyderabad
01.2021 - 03.2021
  • Company Overview: Hyderabad
  • Evaluating medication therapy and making appropriate recommendations to patients or health practitioners.
  • Oversaw operations to reduce error rate by 15 percent and meet objectives.
  • Provided counseling to patients and community members in need of additional information related to safe drug use and selection.
  • Hyderabad

Education

DOCTOR OF PHARMACY -

Kerala University of Health Science
India
01.2020

Skills

  • Written and verbal communication
  • Leadership and team building
  • Critical thinking
  • Problem solving
  • Risk assessment
  • Signal detection
  • Medical review
  • Quick learning
  • Multitasking
  • Time management
  • Clinical decision-making

Awards

  • Excellence Award, 2023, 4C Pharma Solutions
  • Best Employer Award, 2022, Indegene
  • Best Performer Award, 2021, IQVIA

Languages

English
First Language
Malayalam
Proficient (C2)
C2
Hindi
Intermediate (B1)
B1
Tamil
Proficient (C2)
C2
Arabic
Intermediate (B1)
B1

Disclaimer

I declare that the information provided above is true to best of my knowledge.

Timeline

PMS Complaint Handling Investigator

4C Pharma Solutions
10.2022 - Current

Safety Physician II (Medical Reviewer)

INDEGENE
11.2021 - 10.2022

Drug Safety Associate

IQVIA MEDICAL COMPANY
03.2021 - 11.2021

Clinical Pharmacologist

APOLLO HOSPITALS
01.2021 - 03.2021

DOCTOR OF PHARMACY -

Kerala University of Health Science

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Lakshmi Suvarna